- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Sr Director, Global Regulatory Strategy, Neuroscience** + Will be a key member of the GRSP ... Leadership Team to ensure the development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area. + Acts… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director, Global Regulatory Project Management (AD, Global RPM) is a strategic leader responsible for translating and ... executing regulatory strategies across the global drug development lifecycle. This...with senior stakeholders and cross-functional teams (clinical, medical, safety, CMC , commercial) across regions to achieve strategic business goals… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director, Global Regulatory Project Management (Director, Global RPM) is a senior strategic leader responsible for supporting, ... influencing, translating, and executing oncology regulatory strategies across the global drug development lifecycle. This role combines deep regulatory expertise… more
- Parexel (Nashville, TN)
- Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional ... to join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client...in line with local legislation (renewals, PSURs, label updates, CMC changes). * Execute timely data entry and validation… more
- Chiesi (Cary, NC)
- …feedback. Who we are looking for This is what you will do As a Regulatory Affairs Intern within Chiesi Global Rare Diseases, you will gain hands-on exposure to the ... end-to-end regulatory lifecycle of innovative therapies for rare diseases in... strategy discussions and selected cross-functional meetings (eg, Clinical, CMC , Quality, Commercial). + Supporting internal process improvement initiatives,… more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. Regulatory Policy and Intelligence - US Director **Live** **What you will do** Let's do ... this. Let's change the world. Global Regulatory Policy team engages regulators, industry and professional associations, and patient advocates externally and subject… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** Are you ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- University of Maryland, Baltimore (Baltimore, MD)
- …This program covers all major areas of drug product and biologics regulatory science, including: Chemistry, Manufacturing, and Controls ( CMC ); Clinical Research; ... fulfill the faculty position of Instructor (non-tenure track) for the MS in Regulatory Science within the Department of Pharmaceutical Sciences. The MS in … more
- Takeda Pharmaceuticals (Boston, MA)
- …to increase business performance, organizational efficiency while increase speed for CMC deliverables, including AI-forward projects and mindset. + Partner with PS, ... to identify, prioritize, and lead enterprise-wide transformation initiatives, with a focus on increasing CMC productivity of a minimum 5% per year and ensure CMC … more
- ICON Clinical Research (Blue Bell, PA)
- …medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). Vendor ... as needed. Supports inspection team in preparation for and during regulatory agency inspection. Study Team Interaction + Represents Clinical Logistics/Supply… more